Tissue Allograft for Prostate Cancer

(RAP Trial)

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: 5-phosphodiesterase inhibitors

Must not be taking: Immunosuppressants, Chemotherapy, Hormonal therapy

Disqualifiers: Obesity, Neurologic disorder, Psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Immediate (during surgery)

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after nerve-sparing robot-assisted radical prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being. The goal of nerve-sparing radical prostatectomy is to preserve erectile and urinary function, but damage to the surrounding nerves and blood vessels can still occur causing the patient to experience the complications. An allograft is the transplant of an organ, tissue, or cells from one individual to another individual of the same species who is not an identical twin. The MLG-Complete allograft is made up of perinatal tissue and is placed on the nerve bundles during a nerve-sparing RARP. It is meant to serve as a barrier and provide coverage to the nerve bundles from the surrounding environment, which may improve post-nerve-sparing RARP complications.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, chemotherapy, or hormonal therapy, you may not be eligible to participate.

How does the treatment MLG-Complete differ from other prostate cancer treatments?

MLG-Complete, used in the Tissue Allograft for Prostate Cancer trial, is unique because it involves the use of tissue allografts, which are transplants of tissue from a donor to a recipient. This approach is different from standard treatments like surgery, radiation, or hormone therapy, as it potentially leverages the body's immune response to target cancer cells, similar to how some immunotherapies work. ^{1 2 3 4 5}

Research Team

Ram A. Pathak, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for men with localized prostate cancer who are undergoing nerve-sparing robot-assisted radical prostatectomy (RARP). It aims to see if wrapping nerves with a new tissue graft can reduce complications like erectile dysfunction and urinary incontinence after surgery.

Inclusion Criteria

Patient has the willingness to comply with follow-up surveys

Negative urinalysis within 30 days prior to date of surgery

Patient has no erectile dysfunction (SHIM score ≥ 19) prior to date of surgery

Exclusion Criteria

Is allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin)

Patients with poor urinary control at baseline requiring the use of pads for leakage

Patients with obesity defined as body mass index (BMI) > 40 kg/m^2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of MLG-Complete allograft to nerve bundles during standard of care nerve-sparing RARP

Immediate (during surgery)

1 visit (in-person, surgical)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and continence

12 months

Multiple visits at 6 weeks, 3, 6, and 12 months post-RARP

Long-term follow-up

Extended monitoring for adverse events and quality of life changes

Up to 12 months post-RARP

Treatment Details

Interventions

• MLG-Complete

Trial Overview The intervention being tested is the use of MLG-Complete, a multi-layer perinatal tissue allograft, wrapped around nerves during RARP. The study will assess its feasibility and effectiveness in improving post-surgical outcomes compared to standard procedures.

Participant Groups

Group I: Supportive care (MLG-Complete allograft) Experimental Treatment 2 Interventions

Patients undergo placement of MLG-Complete allograft to nerve bundles over 5 minutes during standard of care nerve-sparing RARP.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Tumor-infiltrating lymphocytes from human prostate tumors reveal anti-tumor reactivity and potential for adoptive cell therapy. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Allogeneic whole-tumour cell vaccination in the rat model of prostate cancer. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Prostate cancer immunotherapy: beyond immunity to curability. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Establishment of short-term primary human prostate xenografts for the study of prostate biology and cancer. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Human prostatic adenoma and carcinoma. Transplantation of cultured cells and primary tissue fragments in "nude" mice. [2004]